1. Field of the Invention
The invention relates to a biopsy needle system, a biopsy needle and a method for obtaining a tissue biopsy specimen with the system.
2. Description of the Related Art
The most critical diagnosis in medicine is the presence or absence of malignancy. Although there are many screening tests: patient awareness, physical exams, blood tests, and new imaging systems, the hallmark of the cancer diagnosis is a physical specimen, or biopsy, for microscopic analysis.
Malignancy is of life or death importance, so that the quality of the biopsy is of utmost importance. Open surgical biopsy, with total control of specimen location, size, and condition, is the accepted standard of diagnostic quality and a minimally invasive, percutaneous or endoscopic biopsy must not sacrifice that quality, since a false negative may condemn the patient to an agonizing and preventable death.
Obtaining tissue is more difficult by any remote biopsy technique, but quality still relies on obtaining tissue of and from the suspected mass. Therefore, location of needle placement, tissue coring and preserving of the biopsy specimen are of critical importance.
New imaging systems improve needle placement, but with prior art biopsy needles, the actual capture of the biopsy specimen remains unsure and partially blind. The complex multi-motion sequencing of the typical side-cut biopsy needle is so demanding on operator skill, that even automation has not made it totally reliable.
A simple, one-motion, true end-cutting, core biopsy needle, which cleanly and safely shear-cuts straight ahead from the initial approach positioning, yet not blindly, would be an advancement in the art.
Endoscopic biopsy graspers and percutaneous biopsy needles generally recover limited, thin, short, slivers of tissue, making microscopic analysis and diagnosis difficult. An end-cutting, core biopsy needle, which recovers full-lumen specimens of almost unlimited length, would be an advancement in the art.
With the prior art, the biopsied tissue is frequently ripped, compressed, distorted or even crushed, limiting analysis and diagnosis. Fine needle aspiration biopsy, where the tissue is intentionally ripped into small segments or even single cell clusters, is so destructive to intracellular and intercellular anatomy that it is unwise to use that technique as any more than a screening test. Their cytology debris fields are of such poor condition, that although they can occasionally include the diagnosis of malignancy, they seldom exclude it.
An end-cutting, core biopsy needle that is totally non-traumatic to tissue and preserves intracellular and intercellular anatomy would be an advancement in the art.